Demo

Quality Control Lead

Lenkbar LLC
Naples, FL Full Time
POSTED ON 4/21/2025
AVAILABLE BEFORE 5/16/2025

Job Description

Job Description

About the Company

Intech is a global market leader and game-changer in the manufacturing of orthopedic medical devices. It all starts with innovation, and nobody knows this better than Intech. With manufacturing facilities around the world and unique initiatives and savoir-faire, Intech is at the forefront of technological innovation in the field of orthopedic device manufacturing as well as asset management, ensuring that optimal patient care is delivered day in, day out. This is who we are. We tech care.

Here at Lenkbar we give our customers the competitive edge in today's highly specialized design and development of cutting tools. We assist with the design and production of a variety of drills, burrs and taps for the orthopedic industry and world class flexible shafts to meet our customers' most demanding requirements. From Swiss turning to precision grinding, we leverage advanced machining techniques and best-in-class equipment that are automated and optimized for performance to support our customers' next critical product launch.

Position Summary :

Responsible for maintaining quality assurance, performing inspections and quality control testing for analysis of materials, in process, and finished products, recording and analyzing data, Assist Quality Assurance / Quality Control Manager with the execution of day-to-day quality control activities.

Job Duties and Tasks

  • Performs and documents dimensional inspections on parts per order specifications and company quality control policies.
  • Review discrepant material and render final decision for scrap, rework or use as is.
  • Provide supervision support, leadership and guidance to all employees on quality related matters.
  • Work and confer will all necessary departments to exchange required technical and customer information, as well as to proactively address issues.
  • Investigate and determine cause of non-conforming material using root cause analysis techniques.
  • Read customer drawings to interpret requirements including dimensional, physical, functional, and visual requirements.
  • Inspect product for various quality issues using approved methods and procedures.
  • Perform part inspection and measure dimensions of incoming, in process, and finished workpieces to ensure conformance to print specifications.
  • Conduct and document first piece inspections as required.
  • Document and communicate testing and inspection results to ensure quality control standards are satisfied.
  • Place non-conforming production on "hold" status and complete NCR paperwork.
  • Verify and support dispositions of nonconforming product whether internal or customer returns through an RMA procedure.
  • Communicate with manufacturing, engineering, and production personnel from all departments to exchange pertinent information and problem solve issues.
  • Assist with corrective and preventative actions are required.
  • Meet and maintain established efficiency and effectiveness standards established for the quality function.
  • Ensure proper and complete documentation for all inspection paperwork along with all data in the system.
  • Complete all documentation per ISO 13485 and FDA requirements.
  • All other duties as assigned.

Key Skills, Knowledge and Competencies :

  • Minimum of 3 years of quality control experience in a medical device company.
  • Prior material review experience and ability to render final decision for discrepant material.
  • Experience is ISO / FDA environment ,
  • Ability to read and interpret blueprints, knowledge and understanding of GD&T
  • Proficient in the use of machine shop precision measuring equipment including micrometer & caliper, height stands, thread gages, dial indicators, gage pins, radius gages, optical comparator and vision machines.
  • Knowledge of the company quality system.
  • Proficient in the use of a computer in a Windows environment, and proficient in Microsoft Excel.
  • Proficient in math, including the ability to add, subtract, multiply and divide.
  • Excellent manual dexterity, hand / eye coordination.
  • Ability to be highly accurate with a high attention to detail.
  • Ability to troubleshoot and problem solve quality and other issues.
  • Ability to read and comprehend work instructions.
  • Ability to maintain a sense of urgency, handle stressful situations, multitask and ability to prioritize work.
  • Ability to work in a team environment as well as autonomously.
  • Ability to communicate and interact effectively, professionally and constructively.
  • Education, Certifications, and / or Licenses Requirements :

  • High school diploma or equivalent
  • ISO 13485 : 2016
  • Work Environment :

  • The noise level in the work environment is usually moderate.
  • Includes exposure to sounds and noise levels that can be distracting or uncomfortable.
  • Includes exposure to moving mechanical parts.
  • Includes exposure to coolants and oils.
  • Work environment is temperature controlled.
  • The work environment described here is representative of that which an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Physical Requirements :

  • While performing the duties of this job the employee is regularly required to sit, stand or walk; use hands, handle, or feel objects, tools or controls; reach with hands and arms; talk and hear.
  • Ability to lift and / or move up to 50 pounds.
  • Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
  • Ability to sit for up to 12 hours per day.
  • Requires repetitive movement.
  • Requires bending and twisting.
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